Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effect of Calcitriol on Progress and Activity of Lupus Nephritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01863641
Recruitment Status : Unknown
Verified May 2013 by Alireza Amir Maafi, Guilan University of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : May 29, 2013
Last Update Posted : May 29, 2013
Sponsor:
Information provided by (Responsible Party):
Alireza Amir Maafi, Guilan University of Medical Sciences

Brief Summary:
The purpose of this study is to determine whether calcitriol is effective in the treatment of lupus nephritis.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Drug: calcitriol Drug: placebo Phase 2

Detailed Description:
Systemic lupus erythematosus (SLE) is an autoimmune disease and renal involvement represent one of the most common manifestations of it . On the other hand, there is evidence that vitamin D and its analogs have known immunosuppressant properties and profound effects on glomerular mesangial cell proliferation. Moreover much literature such as animal studies suggests it as a therapeutic intervention in autoimmune disease. The investigators plan to conduct a double blind randomized control clinical trial to study effects of calcitriol on progress and activity of lupus nephritis. Fifty patients with clinically quiescent SLE and biopsy-proven glomerulonephritis will be recruited. They will be treated with calcitriol for 1 year. Proteinuria, renal function, lupus disease activity, serum inflammatory markers will be monitored.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Calcitriol on Progress and Activity of Lupus Nephritis
Study Start Date : April 2013
Estimated Primary Completion Date : October 2013
Estimated Study Completion Date : April 2014


Arm Intervention/treatment
Experimental: treatment group
Patients will receive calcitriol at a fixed dose daily.
Drug: calcitriol
Patients will receive calcitriol at a fixed dose of 0.25 µg (one oral pearl) daily.

Active Comparator: control group
Patients will receive placebo daily.
Drug: placebo
Patients will receive placebo similar to intervention (shape, color and design) 1 oral unit daily.




Primary Outcome Measures :
  1. change in proteinuria [ Time Frame: baseline and 12 months ]

Secondary Outcome Measures :
  1. risk of lupus flare [ Time Frame: baseline and 12 months ]
  2. change in renal function [ Time Frame: baseline and 12 months ]
    based on the American College of Rheumatology renal response criteria

  3. change in serum inflammatory markers [ Time Frame: baseline and 12 months ]
  4. change in Systemic Lupus Erythematosus Disease Activity Index score [ Time Frame: baseline and 12 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged 18-65 years
  • Baseline Systemic Lupus Erythematosus Disease Activity Index score <= 4
  • Estimated glomerular filtration rate more than 15 ml/min/1.73m2
  • Proteinuria > 1 g/day (or proteinuria > 1 g/g-Cr) in 2 consecutive samples within 12 weeks despite ACE inhibitor at least 3 months
  • On maintenance dose of prednisolone < 15 mg/day with or without other immunosuppressive medications
  • Serum calcium level in normal range( 8.5-10.5 mg/dl)
  • History of biopsy-proven lupus nephritis clinical quiescent SLE for at least 3 month
  • Willingness to give written consent and comply with the study protocol

Exclusion Criteria:

  • Pregnancy, lactating or childbearing potential without effective method of birth control
  • Severe gastrointestinal disorders that interfere with their ability to receive or absorb oral medication
  • History of malignancy, including leukemia and lymphoma within the past 2 years; Systemic infection requiring therapy at study entry
  • Any other severe coexisting disease such as, but not limited to, chronic liver disease, myocardial infarction, cerebrovascular accident, malignant hypertension
  • History of drug or alcohol abuse within past 2 years
  • Vitamin D deficiency(25 hydroxy vitamin D less than 20ng/ml)
  • Participation in any previous trial on vitamin D analogue
  • Patients receiving treatment of vitamin D and/or its analogue for other medical reasons within the past 4 weeks
  • Patients who are taking multivitamin supplement that contains vitamin D could be enrolled after 4 weeks of wash out period by changing to a preparation that has no vitamin D
  • On other investigational drugs within last 30 days
  • History of a psychological illness or condition such as to interfere with the patient's ability to understand the requirement of the study
  • History of non-compliance; Known history of sensitivity or allergy to vitamin D analogs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01863641


Contacts
Layout table for location contacts
Contact: Alireza Amir Maafi, MD Student 00989376036481 alireza.am427@gmail.com

Locations
Layout table for location information
Iran, Islamic Republic of
Razi hospital Recruiting
Rasht, Guilan, Iran, Islamic Republic of
Contact: Alireza Amir Maafi, MD Student    00989376036481    alireza.am427@gmail.com   
Sponsors and Collaborators
Guilan University of Medical Sciences
Investigators
Layout table for investigator information
Study Chair: Banafsheh ghavidel parsa, MD Guilan University of Medical Sciences, Iran
Principal Investigator: Alireza Amir Maafi, MD Student Student Research Committee, Guilan University of Medical Sciences, Rasht, Iran

Layout table for additonal information
Responsible Party: Alireza Amir Maafi, Minister of Student Research Committee, Guilan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01863641     History of Changes
Other Study ID Numbers: 1910354604
IRCT2013030912762N1 ( Registry Identifier: Iranian Registry of Clinical Trials )
First Posted: May 29, 2013    Key Record Dates
Last Update Posted: May 29, 2013
Last Verified: May 2013
Keywords provided by Alireza Amir Maafi, Guilan University of Medical Sciences:
lupus nephritis
proteinuria
SLE
calcitriol
Additional relevant MeSH terms:
Layout table for MeSH terms
Calcitriol
Nephritis
Lupus Nephritis
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Kidney Diseases
Urologic Diseases
Glomerulonephritis
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Vitamins
Micronutrients
Nutrients
Growth Substances
Bone Density Conservation Agents